eSTAR submissions overview and live Q&A with FDA

Starting October 1, 2023, all 510(k) submissions, unless exempted, must be submitted electronically using eSTAR. What do you need to do to prepare? Patrick Axtell, Assistant Director for Tools and Templates Team, and Sajjad Syed, Software Engineer for Tools and Templates Team, from FDA joined our panel of Rimsys experts, Bruce McKean and James Gianoutsos, for an introduction to eSTAR, eSTAR demo, and Q&A session. Watch the replay to gain valuable insights to help you prepare for eSTAR submissions!